Regulatory

UK passes post-Brexit medical device regulatory bill into law

The cornerstone of the UK’s post-Brexit medical device regulatory system, the Medicines and Medical Devices Act 2021, received royal assent and passed into law on February 11, having been introduced in the House of Commons almost a year previously. The bill mirrored the focus on patient safety found in the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), providing mechanisms for punishing regulatory violations and releasing information about products that pose a threat to public safety.

(EMERGO 2/28/21)

US FDA appoints new director for medical device cybersecurity 

FDA has appointed Kevin Fu, an associate professor at the University of Michigan, Acting Director of Medical Device Cybersecurity. This role is a new one created within the Center for Devices and Radiological Health (CDRH), specifically located in the Office of Strategic Partnerships and Technology Innovation. Fu’s appointment reflects the FDA’s increased interest in medical device cybersecurity in recent years.The agency has paid special attention recently to cybersecurity considerations for software as a medical device (SaMD) product, laying out the first steps in a new certification framework and publishing an action plan for regulating SaMD that uses artificial intelligence or machine learning.

(EMERGO- 02/09/2021)

First-in-world 3D printed bone replacement okayed by CDRH 

FDA has issued a first-in-world approval for a customized 3D-printed bone replacement. The Patient Specific Talus Spacer is designed to replace the talus bone, which sits at the top of the foot and forms part of the ankle joint, in patients with avascular necrosis (AVN) of the ankle. Patients with ankle joint AVN number fewer than 8,000 yearly in the US, but the condition presents patients and their caregivers with dire options: when AVN degrades the talus, the ankle joint is unstable, making walking extremely painful or even impossible. Choices include ankle fusion, which eliminates motion of the joint and affects gait, or amputation of the leg below the knee.

(RAPS- 02/18/2021)

FDA warns pulse oximeters less accurate for people with darker skin

Pulse oximeters, devices used for estimating blood oxygen levels, may be less accurate in people with darker skin pigmentation, the FDA warns. The tools are often used by patients at-home to monitor conditions, however the FDA cautioned that the technology have limitations and a risk of inaccuracy under certain conditions. While the agency doesn’t explicitly mention race, it cites a recent report published in The New England Journal of Medicine, which found, in two large cohorts of patients, “Black patients had nearly three times the frequency of occult hypoxemia that was not detected by pulse oximetry as white patients.” The agency went on to detail that poor circulation, skin pigmentation, skin thickness, skin temperature, the use of tobacco and fingernail polish can all have an effect on the device’s accuracy. The agency is now taking action to look into possible issues with the devices.

(MobiHealthNews 2/22/21)

FDA’s enforcement discretion for digital health is more ambiguous than ever in 2021

Companies that fall above or below the line of enforcement discretion will still be responsible and must maintain the burden of proof for their products. “Enforcement discretion doesn’t mean no regulation,” Ankur Kaushal, VP of regulatory affairs and quality at Big Health, said in DTx West virtual panel. “It doesn’t mean that the FDA is no longer in your life. The FDA is very much there. Regulations are still very much present. There’s many more companies that have been touched by this distinction between active regulation and enforcement discretion, and I think the agency has tried to support that broader reach of enforcement discretion policies with more active articulation of what enforcement discretion really means. … It’s still evolving, and I think it’s still spotty as to the consistency of how these policies are applied, and how companies are interpreting ways to distinguish products that are the focus of regulation from those that are under enforcement discretion.”

(MobiHealthNews 2/25/21)

FDA Adds New Regulatory Science Tools for Assessing Medical Devices

FDA recently added five tools to its catalog of regulatory science tools to help assess medical devices, including multifunctional method for quantitative evaluation of time-dependent eye hazard from laser pointers and a battery of image quality test methods for evaluation of fluorescence imaging systems.

(MDDI 2/1/21)

Payment

4 predicted trends for 2021 are influenced by the lingering effects of COVID 

Four trends were forecast for 2021, describing changes that providers and payers may see as a result of the COVID-19 pandemic. The first prediction is an acceleration of value-based care and insurer partnerships. The next prediction is a shift in payer composition with a reduction of beneficiaries enrolled in commercial plans and an increase in the number of people relying on Medicaid and self-pay as a high number of people continue to lose employment. The next predicted trend is that the focus on telehealth will continue throughout 2021, and likely beyond, as more patients and providers have experienced the advantages of healthcare available in the home. The last prediction is an increased focus on healthcare inequality in reaction to deep racial disparities exposed by COVID infection and mortality rates.

(HealthCare Dive 1/22/21)

Reduced Medicare reimbursement rates cause iRhythm stock to plummet 

Novitas Solutions, a Medicare Administrative Contractor (MAC) posted an update to their reimbursement rate list which included a 70%+ reduction in the expected payments for the iRhythm Technologies Zio patch, a mobile cardiac telemetry device. Although Medicare patients only represent an anticipated 25% of revenue, it is noted that commercial payers tend to follow the lead that is set by the MAC reimbursement. The announced rates may not yet be set in stone, as the list is typically not finalized until the end of the month, however, the uncertainty created by the announcement was enough to spook investors.

(MDDI 2/22/21)

Wisconsin Children’s Community Health Plan offers digital therapeutic to Medicaid members 

Children’s Community Health Plan (CCHP) is making Freespira, an FDA-cleared digital therapeutic available to all members. Freespira is a medication-free treatment for panic attacks, panic disorders, and post-traumatic stress disorder in adolescents and children. In a statement, CCHP’s chief operating officer stated that the decision to offer the digital therapeutic was driven by evidence of efficacy and cost-reduction. He describes the program as a “win-win”. The decision to offer access to this treatment comes at a time when nearly 3 million US children have been diagnosed with a serious emotional or behavioral health condition during the pandemic, according to the Centers for Disease Control.

(PR Newswire 2/10/21)

 

The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Simbex Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.